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Last Updated: November 25, 2020

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PREPOPIK Drug Profile

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Which patents cover Prepopik, and when can generic versions of Prepopik launch?

Prepopik is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-one patent family members in twenty-four countries.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Prepopik

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2021. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $5mm indicating the motivation for generic entry (peak sales were $18mm in 2015).

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for PREPOPIK
Drug Prices for PREPOPIK

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Drug Sales Revenue Trends for PREPOPIK

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Generic Entry Opportunity Date for PREPOPIK
Generic Entry Date for PREPOPIK*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SOLUTION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PREPOPIK

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Cleveland ClinicPhase 4
Ferring PharmaceuticalsPhase 4
Ferring PharmaceuticalsPhase 3

See all PREPOPIK clinical trials

Paragraph IV (Patent) Challenges for PREPOPIK
Tradename Dosage Ingredient NDA Submissiondate
PREPOPIK FOR SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 202535 2014-05-21

US Patents and Regulatory Information for PREPOPIK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.